Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Hebei Tumor Hospital

ClinicalTrials.gov Identifier:

NCT01737216

First received: November 27, 2012

Last updated: December 28, 2012

Last verified: November 2012

History of Changes

Purpose

Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.

Condition	Intervention	Phase
Lung Cancer	Drug: Zoledronic acid plus EP/TP Drug: EP/TP	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Hebei Tumor Hospital:

Primary Outcome Measures:

Progression-free survival(PFS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall survival(OS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Bone mineral density(BMD) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Quality of life(QOL) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	100
Study Start Date:	November 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zoledronic acid plus First-line chemotherapy	Drug: Zoledronic acid plus EP/TP Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression
Active Comparator: First-line chemotherapy	Drug: EP/TP Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Other Name: First-line chemotherapy

Eligibility


Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent form
Age ≥70 years
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
Histologically or cytologically confirmed lung cancer
Did not receive bisphosphonate treatment

Exclusion Criteria:

Appear relapse and metastasis
receive other bisphosphonate treatment
Active or uncontrolled infection
Pregnant or lactating women

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737216

Locations


China, Hebei
Hebei Tumor Hospital
Shijiazhuang, Hebei, China, 050011

Sponsors and Collaborators

Hebei Tumor Hospital

Investigators


Principal Investigator:	Wei Liu	Hebei Tumor Hospital

More Information

No publications provided


Responsible Party:	Hebei Tumor Hospital
ClinicalTrials.gov Identifier:	NCT01737216 History of Changes
Other Study ID Numbers:	HBTH201, Hebei Tumor Hospital
Study First Received:	November 27, 2012
Last Updated:	December 28, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Hebei Tumor Hospital:


Aged patients

Additional relevant MeSH terms:


Zoledronic acid Bone Density Conservation Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015

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